Closure of patent foramen ovale in “cryptogenic” stroke: Has the story come to an end?

2018 ◽  
Vol 13 (3) ◽  
pp. 240-242 ◽  
Author(s):  
Jean-Louis Mas ◽  
Gilles Chatellier
Keyword(s):  
Antiplatelet Therapy ◽  
Patent Foramen Ovale ◽  
Oral Anticoagulants ◽  
Cryptogenic Stroke ◽  
Stroke Recurrence ◽  
Foramen Ovale ◽  
Permanent Disability ◽  
Increased Risk ◽  
Procedural Complications

Contrasting with three randomized trials that failed to show any superiority of patent foramen ovale closure over antithrombotic therapy, two trials recently reported lower rates of stroke recurrence among patients assigned to patent foramen ovale closure than among those assigned to antiplatelet therapy. In addition, one of the initially negative trials concluded in favor of patent foramen ovale closure after an extended follow-up period. A better selection of patients, the use of reference treatment groups that included patients who received antiplatelet therapy alone (rather than antiplatelet drugs or oral anticoagulants, according to physician preference), and a longer follow-up of patients, may explain the divergent findings across studies. Procedural complications were reported in 1.5% to 5.9% of the patients, none of which led to permanent disability or death. Patent foramen ovale closure was associated with an increased risk of new-onset atrial fibrillation in several studies and of venous thromboembolism in one study.

PP122 A Quick Cost-Effectiveness Analysis Of Patent Foramen Ovale Closure In Korean Patients With Cryptogenic Stroke

2018 ◽  
Vol 34 (S1) ◽  
pp. 112-113
Author(s):  
Jeonghoon Ahn ◽  
Eung Ju Kim ◽  
Kyungmi Oh ◽  
Justin Seung-Ho Yoo ◽  
Maria Koullick
Keyword(s):  
Cost Effectiveness ◽  
Prospective Study ◽  
Antiplatelet Therapy ◽  
Patent Foramen Ovale ◽  
Oral Anticoagulants ◽  
Cryptogenic Stroke ◽  
Foramen Ovale ◽  
Effectiveness Analysis ◽  
The Cost ◽  
Pfo Closure

Introduction:Patent foramen ovale (PFO) is an open hole between the right and left upper chambers of the heart. It may increase the risk of stroke, so closure of the hole is considered a secondary prevention in patients who have experienced cryptogenic stroke. Recent evidence has been published on the effectiveness of PFO closure, including a publicly funded prospective study on the effectiveness of PFO closure for preventing recurrent stroke or transient ischemic attack in selected Korean patients who have experienced cryptogenic stroke. The objective of this study was to examine the cost-effectiveness of PFO closure using this recent evidence.Methods:Available clinical data from the aforementioned Korean prospective study and other recent multicenter trials funded by public bodies were used. The cost data were obtained from the current Korean National Health Insurance fee schedule. Utility data were extracted from local research on stroke patients. A cost-effectiveness analysis, based on a 20-year Markov model, was conducted using these data to compare PFO closure plus antiplatelet therapy with oral anticoagulants alone.Results:The initial analysis showed that PFO plus antiplatelet therapy costs KRW 7.13 million (USD 6,547) more than oral anticoagulants alone but has a higher utility of 1.3 quality-adjusted life-years (QALYs) per patient, which corresponds to an incremental cost-effectiveness ratio (ICER) of KRW 5.6 million (USD 5,142) per QALY. The implicit Korean ICER threshold is KRW 25 million (USD 22,955) for non-cancer drugs, so it seems that PFO plus antiplatelet therapy is cost effective in the Korean setting.Conclusions:Since this study used some transition probabilities from foreign sources, the results may not be completely transferable to the Korean setting. However, this is the best available evidence so far in Korea for the economic evaluation of the PFO closure procedure. Therefore, use of PFO closure in carefully selected patients with a history of cryptogenic stroke may benefit the public payer in Korea.

scholarly journals Patent foramen ovale closure, antiplatelet therapy or anticoagulation in patients with patent foramen ovale and cryptogenic stroke: a systematic review and network meta-analysis incorporating complementary external evidence

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e023761 ◽  
Author(s):  
Hassan Mir ◽  
Reed Alexander C Siemieniuk ◽  
Long Cruz Ge ◽  
Farid Foroutan ◽  
Michael Fralick ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Antiplatelet Therapy ◽  
Major Bleeding ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Persistent Atrial Fibrillation ◽  
Stroke Recurrence ◽  
Foramen Ovale ◽  
External Evidence ◽  
Pfo Closure

ObjectiveTo examine the relative impact of three management options in patients aged <60 years with cryptogenic stroke and a patent foramen ovale (PFO): PFO closure plus antiplatelet therapy, antiplatelet therapy alone and anticoagulation alone.DesignSystematic review and network meta-analysis (NMA) supported by complementary external evidence.Data sourcesMedline, EMBASE and Cochrane CENTRAL.Study selectionRandomised controlled trials (RCTs) addressing PFO closure and/or medical therapies in patients with PFO and cryptogenic stroke.Review methodsWe conducted an NMA complemented with external evidence and rated certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.ResultsTen RCTs in eight studies proved eligible (n=4416). Seven RCTs (n=3913) addressed PFO closure versus medical therapy. Of these, three (n=1257) addressed PFO closure versus antiplatelet therapy, three (n=2303) addressed PFO closure versus mixed antiplatelet and anticoagulation therapies and one (n=353) addressed PFO closure versus anticoagulation. The remaining three RCTs (n=503) addressed anticoagulant versus antiplatelet therapy. PFO closure versus antiplatelet therapy probably results in substantial reduction in ischaemic stroke recurrence (risk difference per 1000 patients over 5 years (RD): −87, 95% credible interval (CrI) −100 to −33; moderate certainty). Compared with anticoagulation, PFO closure may confer little or no difference in ischaemic stroke recurrence (low certainty) but probably has a lower risk of major bleeding (RD −20, 95% CrI −27 to −2, moderate certainty). Relative to either medical therapy, PFO closure probably increases the risk of persistent atrial fibrillation (RD 18, 95% CI +5 to +56, moderate certainty) and device-related adverse events (RD +36, 95% CI +23 to +50, high certainty). Anticoagulation, compared with antiplatelet therapy, may reduce the risk of ischaemic stroke recurrence (RD −71, 95% CrI −100 to +17, low certainty), but probably increases the risk of major bleeding (RD +12, 95% CrI −5 to +65, moderate certainty).ConclusionsIn patients aged <60 years, PFO closure probably confers an important reduction in ischaemic stroke recurrence compared with antiplatelet therapy alone but may make no difference compared with anticoagulation. PFO closure incurs a risk of persistent atrial fibrillation and device-related adverse events. Compared with alternatives, anticoagulation probably increases major bleeding.PROSPERO registration numberCRD42017081567.

close: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design

2016 ◽  
Vol 11 (6) ◽  
pp. 724-732 ◽  
Author(s):  
Jean-Louis Mas ◽  
Geneviève Derumeaux ◽  
Pierre Amarenco ◽  
Caroline Arquizan ◽  
Pierre Aubry ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Study Design ◽  
Patent Foramen Ovale ◽  
Oral Anticoagulants ◽  
Stroke Recurrence ◽  
Foramen Ovale

scholarly journals Atrial fibrillation screening on holter monitoring after percutaneous patent foramen ovale closure: a prospective study

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
F Leclercq ◽  
X Odorico ◽  
C Arquizan ◽  
J C Macia ◽  
B Lattuca ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Adverse Outcomes ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
Increased Risk ◽  
Pfo Closure ◽  
New Onset

Abstract Background An increased risk of new-onset atrial fibrillation (AF) after patent foramen ovale (PFO) closure was observed in randomized trials. However, systematic screening of AF was not performed in these studies. Purpose We aimed to evaluate incidence of AF in patients undergoing percutaneous PFO closure with serial 24-hours ambulatory electrocardiogram (AECG) monitoring during a 6-months follow-up. Methods All consecutive patients undergoing PFO closure for cryptogenic stroke or decompression sickness (DSC) were prospectively included in 2 centers. AF was defined as an irregular rhythm without discernible P waves lasting at least 30 seconds on 24-hours AECG performed at day 0, 1 month and 6-months follow-up. Primary endpoint was incidence of AF within the study period. Secondary endpoints evaluated clinical outcomes (hospitalization for cardiovascular causes, new stroke or bleeding) within 6-months follow-up. Results Between February 2018 and March 2019, a total of 62 patients underwent PFO closure: 59 (95.2%) for cryptogenic stroke and 3 (4.8%) for DSC. In the overall population, 40 were male (64.5%) and the mean age was 48±9.5 years. An atrial septal aneurysm was present in 37 patients (64.9%). The PFO device mean size was 26±5.0 mm. After a mean follow-up of 33.3±12.2 weeks, new-onset AF occurred in 3 patients (4.8%), all within 1-month after closure and paroxysmal. While symptomatic ectopic atrial heart beats occurred in one fourth of patients, all AF episodes asymptomatic. Two patients (3.2%) required oral anticoagulant therapy according to CHA2DS2-VASc score. No adverse outcomes occurred. Age (RR 1.26 [0.98; 1.61] p=0.3), male sex (p=0.6) and device (p=1.0) were not associated with occurrence of AF but all patients with AF were men and received an Amplatzer device. Conclusion Incidence of AF, evaluated with serial systematic 24-hours AECG during a 6-months follow-up after PFO closure, was relatively low (&lt;5%). Always paroxysmal, AF always occurred within one month after the procedure and was not associated with adverse outcomes. FUNDunding Acknowledgement Type of funding sources: None.

Abstract WP264: Frequency of Hypercoagulability in Patients With Embolic Stroke of Undetermined Source and Patent Foramen Ovale

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Michael Liu ◽  
Srikant Rangaraju ◽  
Alexander Duncan ◽  
Samir Belagaje ◽  
Trina Belair ◽  
...  
Keyword(s):  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Paradoxical Embolism ◽  
Embolic Stroke ◽  
Composite Outcome ◽  
Foramen Ovale ◽  
Primary Mechanism ◽  
Detailed Evaluation ◽  
D Dimer

Introduction: Patent foramen ovale (PFO) is more commonly found in patients with cryptogenic stroke and paradoxical embolism is commonly assumed to be the primary mechanism. Our objective was to determine the frequency of hypercoagulability in cryptogenic stroke patients and PFO. Methods: Consecutive patients with embolic stroke of undetermined source (ESUS) seen at the Emory Clinic from January 1, 2017 to June 30, 2019 who underwent echocardiogram with bubble study and markers of coagulation and hemostatic activation (MOCHA) testing (serum d-dimer, prothrombin fragment 1.2, thrombin-antithrombin complex, fibrin monomer) were included; abnormal MOCHA was defined as ≥ 2 elevated markers. Venous thromboembolism, malignancy, other defined hypercoagulable state, and the composite outcome were assessed at routine follow-up and compared across groups based on PFO status. Results: Of 172 patients (mean age 63 ± 16 years, 60% female), 40 (23%) had a PFO. Compared to the PFO- group, the PFO+ group was younger (p=<0.001), less likely to have hypertension (p<0.001) and diabetes (p=0.011), and had a higher ROPE score (p=0.007) (Table 1). There was no difference in the frequency of abnormal MOCHA between groups and the composite outcome was less frequent in PFO+ versus PFO- patients (p=0.017). In the subgroup of patients <60 years old, there was no difference in the frequency of abnormal MOCHA and the composite outcome. Conclusion: Hypercoagulability as measured by MOCHA was not associated with the presence of PFO in ESUS patients. Based on our results, ESUS patients should undergo a detailed evaluation for alternative causes of stroke other than paradoxical embolism.

scholarly journals Patent foramen ovale closure by using transesophageal echocardiography for cryptogenic stroke: single center experience in 132 consecutive patients

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Yangyang Han ◽  
Xiquan Zhang ◽  
Fengwei Zhang
Keyword(s):  
Body Weight ◽  
Contrast Agents ◽  
Transesophageal Echocardiography ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Percutaneous Closure ◽  
X Rays ◽  
Foramen Ovale ◽  
Pfo Closure

Abstract Background Percutaneous closure of patent foramen ovale (PFO) is routinely performed using plain fluoroscopy in the catheter room. This method results in inevitable radiation damage, adverse effects of contrast agents on kidneys, and high cost. We performed PFO closure with a simplified and economical transesophageal echocardiography (TEE)-only guided approach in the operating room. This study aimed to investigate the feasibility, safety, and effectiveness of the percutaneous closure of PFO by only using TEE. Methods We reviewed the medical records of patients who underwent percutaneous PFO closure at our center from December 2013 to December 2017. A total of 132 patients with PFO and cryptogenic strokes underwent PFO closure by using cardi-O-fix PFO device under TEE guidance. The participants comprised 64 and 68 male and female patients, respectively. The mean age and body weight of the patients were 39.40 ± 13.22 years old (12–68 years old) and 65.42 ± 9.70 kg (40–95 kg), respectively. All patients only received aspirin (3–5 mg/kg body weight, oral administration) for 6 months. Contrast-enhanced transthoracic echocardiography (c-TTE) with Valsalva maneuver was performed during follow-up, and questionnaire surveys were obtained at 3, 6, and 12 months after the procedure. Results All (100%) patients were successfully closed. Follow-ups were conducted for 13 months to 48 months, with an average of 27 months. No severe complications were found during the follow-up period. Paroxysmal atrial fibrillation occurred in 4 patients within 3 months after the procedure. No recurrent stroke or death occurred in all patients during the follow-up period. Transient ischemic attack occurred in one patient 6 months after the procedure. Ten (7.6%) patients had a right-to-left shunt, as demonstrated by c-TTE at 12 months of follow-up. Among the 57 patients suffering from migraine, significant relief or resolution was reported by 42 (73.7%) patients. Conclusion TEE-only guided PFO closure was a safe, feasible, and effective method that did not require the use of X-rays and contrast agents.

scholarly journals P916 RoPE score in causal association between patent foramen ovale and cryptogenic stoke, is it enough?

2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
L Carnero Montoro ◽  
M Ruiz Ortiz ◽  
M Delgado Ortega ◽  
A M Rodriguez Almodovar ◽  
N Paredes Hurtado ◽  
...  
Keyword(s):  
Patent Foramen Ovale ◽  
Incidental Finding ◽  
Cryptogenic Stroke ◽  
Imaging Study ◽  
Interatrial Septum ◽  
Percutaneous Closure ◽  
Stroke Recurrence ◽  
Foramen Ovale ◽  
Complex Anatomy ◽  
History Of

Abstract Introduction The prevalence of patent foramen ovale (PFO) in the general population is high (25%). In patients with cryptogenic stroke (CS) and PFO, determining whether it is causally related to stroke or is an incidental finding is a controversial issue. The RoPE score was described in 2013 to predict the likelihood that the stroke was related to the PFO. The higher the score, the greater the risk of attributable causality, considering 6 as the cut-off point. This scale includes clinical variables, but does not consider the echocardiographic characteristics of PFO that were used as inclusion criteria in studies that have shown benefit with percutaneous closure, such as the complex anatomy of PFO (extensive passage of microbubbles across the PFO at rest and/or interatrial septum aneurysm). Purpose Our aim was to investigate the association of the RoPE score with recurrence of stroke in a series of patients with CS and percutaneously closed PFO in a period of time prior to the current recommendations, as well as to describe the presence of complex anatomy of PFO and its relationship with the value of that score. Methods A series of 172 consecutive patients with CS and percutaneous closure of PFO, included from January 2001 to November 2014 in a single center was analyzed, and the RoPE score was calculated retrospectively in each patient. The presence of complex anatomy of the PFO was estimated by echocardiography, and the rate of recurrence of stroke and the relationship of both variables with the value of the RoPE score was investigated. Results Of the 172 patients in the series, it was possible to calculate the RoPE score in 150 (87%) of them, which constitute the study sample. The mean age was 46 years (range 17-78), 60% were male, 21% were hypertense, 6% diabetic and 27% smokers. A history of previous stroke was present in 3% of patients and 11% had an imaging study with cortical infarction. RoPE score was ≥6 in 69% of the sample, and 66% of the patients presented complex anatomy of PFO, without significant differences between those with RoPE score ≥6 and &lt;6 (65% versus 70%, p = 0.62). Acute complications (mortality, cardiac tamponade, stroke, device embolism) related to closure of the PFO were not observed. After 17.5 years of maximum follow-up (mean 9.6 ± 3.7 years, no patients lost, with a total of 1441 patients-years of observation), 6 patients presented a stroke. The recurrence rate of stroke was very low in both groups of patients, either with RoPE score ≥6 or &lt;6 (0.4 versus 0.5 per 100 patients/year, p = 0.87). Conclusions In our center, before the current recommendations of PFO closure associated with CS, most of the patients had a RoPE score≥6. The majority of patients presented a complex anatomy of the PFO and the incidence of stroke recurrence was very low, independently of the value of the RoPE score.

Atrial septal aneurysms in childhood: prevalence, classification, and concurrent abnormalities

2013 ◽  
Vol 24 (3) ◽  
pp. 453-458 ◽  
Author(s):  
Andreas Giannopoulos ◽  
Christoforos Gavras ◽  
Stavroula Sarioglou ◽  
Fotini Agathagelou ◽  
Irene Kassapoglou ◽  
...  
Keyword(s):  
Atrial Septal Defect ◽  
Patent Foramen Ovale ◽  
Septal Defect ◽  
Interatrial Septum ◽  
Paediatric Population ◽  
Point Of View ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
Increased Risk

AbstractObjectives: This study sought to investigate the prevalence of atrial septal aneurysms in the paediatric population and to define coexisting abnormalities and their incidence. Background: Few papers refer to the prevalence of atrial septal aneurysms in childhood. Methods: We enrolled a total of 4522 children aged more than 12 months who underwent a transthoracic echocardiography. Atrial septal aneurysm was defined as a protrusion of the interatrial septum or part of it >15 mm beyond the plane of the atrial septum or phasic excursion of the interatrial septum during the cardiorespiratory cycle of at least 15 mm in total amplitude and a diameter of the base of the aneurysm of at least 15 mm. Results: Atrial septal aneurysms were found in 47 children (1.04%). They involved almost the entire septum in 14 patients (28.89%) and were limited to the fossa ovalis in 33 (71.11%). An atrial septal aneurysm was an isolated structural defect in 17 (35.56%). In 30 (64.44%) patients, it was associated with interatrial shunting – atrial septal defect and patent foramen ovale. At the echo follow-up after a year, no changes were recorded. Conclusions: Prevalence of atrial septal aneurysms is almost 1%. The most common abnormalities associated are interatrial shunts, that is, a patent foramen ovale and an atrial septal defect. From a medical point of view, it is suggested that no action is to be taken during childhood, as a child with an atrial septal aneurysm is not at increased risk compared with a child without one. Follow-up is scheduled on an individual basis.

scholarly journals Patent foramen ovale closure following cryptogenic stroke or transient ischaemic attack: Long-term follow-up of 301 cases

2015 ◽  
Vol 86 (6) ◽  
pp. 1078-1084 ◽  
Author(s):  
Mikaeil Mirzaali ◽  
Maureen Dooley ◽  
Dylan Wynne ◽  
Nina Cooter ◽  
Lorraine Lee ◽  
...  
Keyword(s):  
Transient Ischaemic Attack ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Foramen Ovale ◽  
Long Term Follow Up ◽  
Ischaemic Attack
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